The disappointment was great when a new Alzheimer's drug was rejected by the EU's pharmaceutical authority (EMA) last summer.
But now EMA has reconsidered its statement – and approves the sale of the drug lecanemab for the treatment of certain Alzheimer's patients. For example, it will not apply to patients with a double set of the Alzheimer's risk gene Apoe4.
In Alzheimer's, plaques form in the form of the protein beta-amyloid, which accumulates in the brain. Lecanemab has been long-awaited because it consists of antibodies that specifically target the protein, unlike today's medicines.
The motivation for EMA's previous decision is that the benefit is not sufficient in relation to potential drawbacks and side effects, such as swelling and risk of bleeding in the brain. In the reconsideration of the decision, EMA finds the benefit of the drug greater than the risks for the limited patient groups.
Lecanemab has been approved in the USA, Japan, South Korea, China, Hong Kong, Israel, and the United Kingdom.
